Posted AtNet India News

The rise of India and China as global
economies presents immense opportunities for the international
pharmaceutical industry. Besieged by ever-increasing
cost pressures, shorter product life cycles and numerous
regulatory challenges in the West, the industry is increasingly
shifting its research and development (R&D) base to
the two developing nations.

This is done to minimise the expenses, time and risk
involved in R&D. During the 90s, the cost of bringing
one new molecule to the market was as high as $800.0
million in developed nations. The European Federation
of Pharmaceutical Industries and Associations (EFPIA)
estimates that on an average out of 10,000 molecules
developed in laboratories, only one or two will successfully
pass all stages of drug development and be commercialised.

If you are interested in an analysis, which provides
manufacturers, end users, and other industry participants
with an overview, summary, advantages and disadvantages
of pharmaceutical R&D outsourcing to India and China
? please send an e-mail to Surbhi Dedhia and Samantha
Unnikrishnan- Corporate Communications at [email protected]/
[email protected] with the following information:
Full name, Company Name, Title, Contact Tel Number,
Contact Fax Number, E-mail. Upon receipt of the above
information, an overview will be e-mailed to you.

Pharmaceutical companies looking for lucrative solutions,
thus, prefer low-cost, developing countries to expensive
R&D in the West. Alliances with local companies, contractual
outsourcing arrangements and establishing local subsidiaries
are good options for enterprises thinking of utilising
the strong intellectual potential in India and China.

"Contract research organisations (CROs) are a popular
option and carry out, on behalf of multiple clients,
medical and scientific studies on a contractual basis,"
says Frost & Sullivan Research Analyst Himanshu Parmar
(http://pharmaceuticals.frost.com). "They provide part
of or all of the processes of clinical research including
clinical trial management, data management, statistical
analysis, protocol design and final report development."

These outsourcing activities in India and China amount
to 20.0 to 30.0 per cent of total global clinical trials.
The competitive advantage here lies in the access to
specialised skills in excellent research institutes
in both countries on a 24/7 basis. In addition, better
management from the start reduces development risks.

Despite these benefits, there has been a relatively
low level of utilisation of the opportunities in both
countries due to various concerns with respect to quality
and infrastructure. Companies are worried about probable
loss of control in processes and proprietary knowledge.
Proper management is needed to utilise complicated and
long-distance collaborative third-party relationships.
Delays can even happen due to regulatory hold-ups.

This has motivated domestic companies and government
in individual countries, keen to increase foreign participation
and to figure prominently on the global map, to implement
necessary changes to improve clinical research facilities.

"Government commitment in India and China to improve
access to high-quality healthcare is a bonus for R&D
outsourcing," opines Parmar. "The regulatory environment
in both countries is gradually changing in favour of
clinical research."

Recent amendments to Schedule Y of Drugs and Cosmetics
Rules of India, 1945, signify progressive attitude on
the part of the Indian Government, clarifying the environment
for clinical research in the country. In China, regular
monitoring of clinical trials ensures good clinical
practice (GCP)-compliant research centres established
by the government. These steps will assist the two countries
attain international standards in pharmaceutical research.

For those companies wishing to utilise the regulatory
changes and high-quality research, considering alliance
strategy and identifying the region of opportunities
should be priorities. Embracing the changes through
innovative strategies and flexibility alone will allow
international pharmaceutical enterprises to capitalise
on these new attractive propositions. Looking ahead
to the increasing trend towards partnerships and alliances
in the pharmaceutical industry, Frost & Sullivan is
organizing a premium event, "Global PharmAlliance 2005
? Becoming the partner of choice" being held at Mumbai
(India) on September 30th and 1st October, 2005.For
more information visit: www.frost.com/pharmalliance

Frost & Sullivan, a global growth consulting company,
has been partnering with clients to support the development
of innovative strategies for more than 40 years. The
company's industry expertise integrates growth consulting,
growth partnership services, and corporate management
training to identify and develop opportunities. Frost
& Sullivan serves an extensive clientele that includes
Global 1000 companies, emerging companies, and the investment
community by providing comprehensive industry coverage
that reflects a unique global perspective and combines
ongoing analysis of markets, technologies, econometrics
and demographics. For more information, visit http://www.frost.com.

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